Vascular closure apparatus and related method

Abstract

A vascular closure device can include both a mechanical component and a biological component for sealing an arteriotomy. The mechanical component reduces the size or closes the arteriotomy. The biological component covers and fills any spaces or cracks present after the arteriotomy has been mechanically reduced in size. An exemplary embodiment includes a suture or clip to approximate the edges of the arteriotomy, and a smooth rounded plug is advanced along the suture towards the closed arteriotomy. An applicator device can be used to deliver the plug and, in particular, the device can include a guidewire that is offset from a central axis along a side of the applicator. In situ, the plug transforms to a flowable or gel state and fills and covers any cracks and spaces along the closed arteriotomy.

We claim: 
     
         1 . A surgical method for closing an open arteriotomy in a blood vessel, said method comprising:
 mechanically approximating a first lip of the arteriotomy to a second lip of the arteriotomy thereby forming a closed arteriotomy;   advancing a sealant in an applicator toward the closed arteriotomy using a guidewire extending from a side of the applicator to aid in positioning the applicator and sealant adjacent the closed arteriotomy; and   ejecting the sealant from the applicator to cover the closed arteriotomy.   
     
     
         2 . The method of  claim 1 , wherein the step of mechanically approximating is carried out with a suture. 
     
     
         3 . The method of  claim 1 , wherein the sealant is spherical in shape. 
     
     
         4 . The method of  claim 1 , wherein the sealant is free from any central hole. 
     
     
         5 . The method of  claim 1 , wherein the applicator includes a side channel for receiving the guidewire therein, adjacent the sealant. 
     
     
         6 . The method of  claim 5 , wherein the side channel is positioned on an exterior of the applicator. 
     
     
         7 . The method of  claim 5 , wherein the side channel is positioned on an interior of the applicator. 
     
     
         8 . The method of  claim 1 , further comprising inserting a sheath into the arteriotomy. 
     
     
         9 . The method of  claim 1 , further comprising lubricating a tissue tract leading to the arteriotomy. 
     
     
         10 . The method of  claim 9 , wherein the lubricating is carried out by sliding the sealant along the tissue tract towards the closed arteriotomy. 
     
     
         11 . The method of  claim 1  wherein the step of covering comprises applying a plug in a first configuration to the closed arteriotomy, and upon the plug being in situ, the plug taking a second configuration. 
     
     
         12 . The method of  claim 11 , further comprising flowing the sealant into tissue cracks in the closed arteriotomy. 
     
     
         13 . The method of  claim 1 , further comprising the step of tamping the sealant against the closed arteriotomy using a pusher member after ejecting the sealant. 
     
     
         14 . The method of  claim 1 , further comprising adjusting the position of the sealant under fluoroscopy. 
     
     
         15 . The method of  claim 1 , further comprising locating the exterior of the vessel wall. 
     
     
         16 . The method of  claim 1 , wherein ejecting the sealant is performed without reinforcing the vessel wall from the inside. 
     
     
         17 . The method of  claim 1 , wherein the applicator defines a central axis, and the sealant is advanced adjacent a guidewire offset from the central axis. 
     
     
         18 . A surgical method for closing an open arteriotomy in a blood vessel, said method comprising:
 placing suture through a first lip and a second lip of an arteriotomy thereby defining a first suture limb and a second suture limb extending from the first lip and the second lip respectively;   approximating the first lip to the second lip of the arteriotomy thereby closing the open arteriotomy into a closed arteriotomy, said closed arteriotomy comprising a slit having at least one micro space;   advancing a sealant towards the closed arteriotomy using an applicator device having a guidewire contained in a side channel adjacent the sealant but not in contact with the sealant;   ejecting the sealant once the applicator is positioned adjacent the closed arteriotomy; and   filling the micro space with the sealant.   
     
     
         19 . The method of  claim 18 , wherein the sealant comprises a central axis, and the guidewire is along an axis offset from the central axis. 
     
     
         20 . A surgical method for closing an arteriotomy in a blood vessel, said method comprising:
 advancing a sealant in an applicator through a tissue tract toward an arteriotomy containing a mechanical closure;   positioning the applicator adjacent the mechanical closure using a guidewire extending from a side channel of the applicator; and   ejecting the sealant from the applicator into the tissue tract in close proximity of the arteriotomy, where upon contact with physiological fluid present in the tissue tract, the sealant expands and infiltrates onto and around the arteriotomy having the mechanical closure.   
     
     
         21 . The surgical method of  claim 18 , wherein the applicator has a rounded distal tip. 
     
     
         22 . The surgical method of  claim 18 , wherein the sealant is spherical in shape and does not contain a central channel therethrough.